Abstract

SIMULTANEOUS ESTIMATION OF METFORMIN AND DAPAGLIFLOZIN TABLETS BY RP-HPLC

Syed Abdul Hadi and Bharath Rathna Kumar P*

ABSTRACT

A simple, rapid, accurate, precise, specific and sensitive reverse phase- HPLC method has been developed and validated for the simultaneous estimation of Metformin and Dapagliflozin in bulk drug and pharmaceutical dosage form. The chromatographic separation was performed on the Kromasil C18 column (250mm×4.6mm, 5μm particle size), using a mobile phase ofBuffer: Acetonitriletaken in the ratio 60:40 v/v, at a flow rate of 1.0 ml/min at an ambient temperatureof 30˚C with the detection wave length at 266nm. The retention times of Metformin and Dapagliflozin were 2.330 min and 3.098 min respectively. The linearity was performed in the concentration range of 125-750 ppm, 1.25-7.5 ppm each of Metformin and Dapagliflozin with a correlation coefficient of 0.999 and 0.999 for Metformin an Dapagliflozin respectively. The percentage purity of Metformin and Dapagliflozin was found to be 99.59% and 99.55% respectively. The proposed method has been validated for specificity, linearity, range, accuracy, precision and robustness were within the acceptance limit according to ICH Q2 (R1) guidelines and the developed method can be employed for routine quality control analysis in the bulk and combined pharmaceutical dosage form of Metformin and Dapagliflozin.

Keywords: Metformin, Dapagliflozin, RP-HPLC, Method development, Method Validation.